The Effect of Wireless Electronic Fetal Monitoring on Labor Pain and Birth Experiences

Официальное название

The Effect of Continuous Wireless Fetal Monitoring During the Intrapartum Period on Labor Pain and Birth Experience: A Randomized Controlled Single-Blind Study

Обзор

This study is using Electronic Fetal Monitoring (EFM) to assess fetal health in pregnant women in labor. This will be compared with continuous wired EFM and continuous wireless EFM. The effects of wireless and continuous wireless EFM on labor pain levels and labor experiences will be measured.

Подробное описание

In this study, Electronic Fetal Monitoring (EFM) is being applied to pregnant women in labor to assess fetal health. This procedure is typically performed in hospitals using a continuous wired EFM. During this period, women are forced to lie down constantly and cannot use active methods to cope with pain. Therefore, using a wireless EFM may be an approach that allows for continuous assessment while also supporting women's activity. Therefore, a comparison will be made between continuous wired EFM and continuous wireless EFM. During labor, pain levels will be assessed using the Visual Analog Scale when cervical dilation is between 8 and 10 cm. After the first hour postpartum, the labor experience of the postpartum woman will be collected using the Birth Experiences Scale.

Вмешательства

• Другое Continuous Wireless EFM Group
  Pregnant women in this group will be continuously assessed with wireless EFM. Because it's a wireless application, pregnant women will have the freedom to move freely throughout labor. They will be able to perform their own activities, such as toileting, and other necessary activities. Pregnant women will not be subjected to any other procedures other than continuous wireless EFM.

Первичные конечные точки

• Birth Experience Questionnaire [Срок оценки: 1 hour after the end of labor]
• The Visual Acuity Scale [Срок оценки: Determining the pain level of pregnant women will be completed within 5 minutes when cervical dilation is 8-10 cm.]

Вторичные конечные точки (1)

• Personal Information Form [Срок оценки: The data will be collected 5 minutes after the pregnant woman is included in the study.]

Критерии участия

Критерии включения

• The study included healthy primiparous or multiparous pregnant women who agreed to participate in the study, were between the ages of 18 and 35, had a gestational age greater than 37+0, had cervical dilation greater than 4 cm, had a single, live fetus, were not using uterotonic agents, spoke Turkish, had no comprehension, perception, or communication problems, and were healthy.

Критерии исключения

• Pregnant women who were diagnosed with a risky pregnancy, who were illiterate, who had a contagious disease, or who had a risky disease were not included in the study.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

Turkey (Türkiye) · 1 центр

• Tokat Gaziosmanpasa University — Tokat Province

Идентификаторы

NCT: NCT07233187 · GaziosmanpasaU-EBE-MŞA-04

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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